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NCT03077360 · ClinicalTrials.gov registry record · NA
Skeletal Muscle Diacylglycerol and Sphingolipids - Impact of Localization and Species on Insulin Resistance in Humans
A NA study of Obesity and Diabetes Mellitus, Type 2, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT03077360 is a NA study of Obesity and Diabetes Mellitus, Type 2 that has completed, run by University of Colorado, Denver. The registered enrollment target is 62 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03077360, a NA study of Obesity and Diabetes Mellitus, Type 2, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
The rationale for the proposed research is that elucidating changes in localized diacylglycerol (DAG) and sphingolipid species that predict insulin sensitivity will reveal specific localized lipids to target in therapeutics for type 2 diabetes. To attain the overall objective, the investigators propose three specific aims: 1. Identify the influence of sarcolemmal DAG and sphingolipids on cell signaling and insulin sensitivity before and after insulin sensitizing lifestyle interventions. Strong preliminary data shape the hypothesis that sarcolemmal 1,2-disaturated DAG and C18:0 ceramide species will decrease after insulin sensitizing lifestyle interventions, leading to less Protein kinase C (PKC) and Protein phosphatase 2A (PP2A) activation, and enhanced insulin signaling. Skeletal muscle DAG and sphingolipid isomers, species, localization, and de novo synthesis will be measured before and after diet-induced weight loss or exercise training interventions in obese men and women. Insulin sensitivity will be measured using insulin clamps, and muscle lipids using Liquid Chromatography Mass Spectrometry (LC/MS). 2. Determine the impact of mitochondrial/ER (endoplasmic reticulum) DAG and sphingolipids on mitochondrial function and ER stress in vivo, before and after insulin sensitizing lifestyle interventions. The investigators hypothesize, again based on preliminary data, that mitochondrial/ER sphingolipids will decrease, yet DAG will increase after insulin sensitizing lifestyle interventions, and each will associate with increased insulin sensitivity. Changes in sphingolipids will relate to increased mitochondrial function, less ER stress, reactive oxygen species (ROS), and acyl-carnitine formation, while changes in DAG will relate to increased mitochondrial content and dynamics. 3. Identify the effect of exogenous DAG and sphingolipids on mitochondrial function in vitro, before and after insulin sensitizing lifestyle interventions. The working hypothesis is that DAG and
Conditions Studied
Interventions
- BEHAVIORAL Lifestyle
Study Locations (1)
Colorado
- University of Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2020-11-19 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03077360
The ClinicalTrials.gov registry entry for NCT03077360 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (92% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Lifestyle is the first listed.
NCT03077360 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT03077360 about?
NCT03077360 is a clinical study titled "Skeletal Muscle Diacylglycerol and Sphingolipids - Impact of Localization and Species on Insulin Resistance in Humans". The rationale for the proposed research is that elucidating changes in localized diacylglycerol (DAG) and sphingolipid species that predict insulin sensitivity will reveal specific localized lipids to target in therapeutics for type 2 diabetes. To attain the overall objective, the investigators prop...
What is the current status of trial NCT03077360?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2017-02-01. Estimated completion is 2020-11-19.
What conditions does trial NCT03077360 study?
This clinical trial studies the following conditions: Obesity, Diabetes Mellitus, Type 2, Pre Diabetes.
What interventions are being tested in trial NCT03077360?
The interventions under investigation include: Lifestyle (BEHAVIORAL).
Who is sponsoring clinical trial NCT03077360?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03077360 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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